Daratumumab-Based Therapeutic Approaches and Clinical Outcomes in Multiple Myeloma and other Plasma Cell Dyscrasias: Insights from a Nationwide Real-World Chart Review Study.

Q4 Health Professions Clinical hematology international Pub Date : 2024-10-11 eCollection Date: 2024-01-01 DOI:10.46989/001c.124362
Allison C Y Tso, Wee Joo Chng, Yeow Tee Goh, Melissa G Ooi, Yunxin Chen, Chandramouli Nagarajan, Daryl Tan, Sanchalika Acharyya, Kiat Hoe Ong
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Abstract

Singapore leads Southeast Asia in the routine use of daratumumab for multiple myeloma and other plasma cell dyscrasias. This retrospective review analyzed 112 patients who received daratumumab between 2012 and 2020. Tolerability, and efficacy based on prior lines (PL) of therapy, cytogenetic risk group, and the presence of renal impairment were presented. Infusion-related reactions occurred in 26.8% of patients. Grades 1 and 2 hematological and non-hematological adverse events were observed in 14.3% and 33.9% of patients, respectively. After a median follow-up of 16.9 months, there was no significant difference in overall response rates (ORR) (86% versus 76.3%, p = 0.082) or depth of response (≥ complete response (CR), 35.1% versus 28.9%, p = 0.469) between myeloma patients with and without renal dysfunction. Newly diagnosed and relapsed/refractory patients had an ORR of 92% and 76.3%, and a ≥ VGPR (very good partial response) rate of 80% and 55.3%, respectively. Median progression-free survival (PFS) was better for patients with 0/1 PL compared to ≥ 2 PLs (19.8 versus 6.2 months, p < 0.001), with a deeper response (≥ CR, 38.5% versus 16.7%, p = 0.033). Forty-six and a half percentage of patients had high-risk FISH abnormalities, and those with 0/1 PL had a significantly better ORR than those with ≥ 2 PLs (83.3% vsersus 47.1%, p = 0.022), achieving an ORR similar to that of the general cohort (80.2%, p = 0.905). In conclusion, positioning daratumumab in earlier lines of therapy leads to better outcomes and may mitigate the impact of high-risk FISH abnormalities.

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多发性骨髓瘤和其他浆细胞瘤的达拉单抗治疗方法和临床疗效:全国真实病历回顾研究的启示》。
新加坡是东南亚地区常规使用达拉单抗治疗多发性骨髓瘤和其他浆细胞异常疾病的领先国家。这项回顾性研究分析了2012年至2020年间接受达拉单抗治疗的112名患者。根据之前的治疗方案、细胞遗传学风险组别以及是否存在肾功能损害,介绍了耐受性和疗效。26.8%的患者发生了输注相关反应。分别有14.3%和33.9%的患者出现了1级和2级血液学和非血液学不良反应。中位随访16.9个月后,有肾功能障碍和无肾功能障碍的骨髓瘤患者在总体反应率(ORR)(86%对76.3%,P = 0.082)或反应深度(≥完全反应(CR),35.1%对28.9%,P = 0.469)方面无明显差异。新诊断患者和复发/难治患者的ORR分别为92%和76.3%,≥VGPR(非常好的部分反应)率分别为80%和55.3%。与≥2个PL的患者相比,0/1个PL的患者的中位无进展生存期(PFS)更好(19.8个月对6.2个月,P<0.001),反应程度更深(≥CR,38.5%对16.7%,P=0.033)。46.5%的患者有高危FISH异常,0/1 PL的患者的ORR显著优于≥2 PL的患者(83.3%对47.1%,p=0.022),达到了与普通队列相似的ORR(80.2%,p=0.905)。总之,将达拉单抗置于较早的治疗方案中可获得更好的疗效,并可减轻高风险FISH异常的影响。
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